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Behavioural Intervention
LEAP Program for Irritable Bowel Syndrome
N/A
Recruiting
Led By Gustavo Zarini, Ph.D., RD
Research Sponsored by Oxford Biomedical Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial found that a tailored anti-inflammatory eating plan, guided by a registered dietitian, improved symptoms in people with irritable bowel syndrome.
Who is the study for?
This trial is for adults with moderate to severe IBS-D, diagnosed by Rome III or IV criteria. Participants must have been on a stable dose regimen for at least a month and be willing to follow the LEAP program for three months. They should not be pregnant, undergoing cancer treatment, have kidney failure, inflammatory bowel disease, celiac disease, or a BMI of 40+.
What is being tested?
The study tests the effectiveness of an anti-inflammatory eating plan tailored to individual needs using LAA-MRT results. It's guided by dietitians over three months and aims to manage symptoms of irritable bowel syndrome (IBS).
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include initial discomfort like bloating as the body adjusts to new foods but are generally expected to be minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Inflammatory blood markers
Secondary study objectives
Gastrointestinal symptoms severity
The quality of life
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ParticipantsExperimental Treatment1 Intervention
Individuals with Irritable Bowel Syndrome (IBS)
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Who is running the clinical trial?
Oxford Biomedical Technologies, Inc.Lead Sponsor
Gustavo Zarini, Ph.D., RDPrincipal InvestigatorOxford Biomedical Technologies, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cancer in the past and are currently receiving treatment for it.You have had kidney failure in the past.You have had a previous diagnosis of a condition called inflammatory bowel disease.You have been diagnosed with celiac disease in the past.You are currently following a different diet plan.You have moderate to severe Irritable Bowel Syndrome (IBS).
Research Study Groups:
This trial has the following groups:- Group 1: Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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